- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05432323
Multi-family Therapy and School Refusal: an Exploratory Study With Adolescents and Their Families (Multi-Fast)
Study Overview
Detailed Description
Anxious school refusal in adolescence is a major public health problem. The involvement of families is essential and multi-family therapy has shown its effectiveness for many mental disorders. This study aims to explore the benefit of multi-family therapy in the care of anxious school refusal in adolescence.
The method will be qualitative with phenomenological analysis of semi-structured interviews with adolescents and their parents and quantitative with a SCED design to assess the evolution of the level of anxiety of adolescents and parents, as well as personalized objectives.
The objective is therefore to improve the care of adolescents with anxious school refusal.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
IDF
-
Paris, IDF, France, 75014
- Maison de Solenn Maison des Adolescents, Cochin Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Families with an adolescent
- Aged 12 to 18
- Totally out of school for more than 2 consecutive weeks and less than 18 months
- Follow-up at the Maison de Solenn-Maison des Adolescents (Cochin Hospital AP-HP) for a school refusal
- Having agreed to participate in a multi-family therapy
- Domiciliation in Ile de France
- Agreement of the parents and the adolescent to participate in the study: Collection of the non-opposition of non-emancipated minors and their legal representatives
Exclusion Criteria:
- any family situation that makes it impossible to bring parents and children together in family therapy
- patient under curatorship or tutorship
- patient with AME (french State Medical Aid)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Adolescents
|
8 sessions of Multi-family therapy of 3 hours each during 24 weeks
|
|
Parents
|
8 sessions of Multi-family therapy of 3 hours each during 24 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale (VAS)
Time Frame: 13 to 15 months
|
Visual Analogue Scale for anxiety (adolescents and parents) / 0 = no anxiety at all, 10 = maximum anxiety imaginable / Weekly measurement between inclusion and the end of the Single Case Experimental Design (SCED) follow-up (13 to 15 months)
|
13 to 15 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Goal Attainment Scale (GAS)
Time Frame: 13 to 15 months
|
School attendance (adolescent) / 3-terminal GAS are 5-level GAS, i.e. with a possible rating ranging from -2 to +2.
Level -2 corresponds to the initial state at the time of inclusion.
Levels -2, 0 and +2 are precisely described, level -1 corresponds to a rating between -2 and 0 and level +1 to a rating between 0 and +2 / Weekly measurements, parents and adolescent, once a week from inclusion to the end of the SCED follow-up (13 to 15 months)
|
13 to 15 months
|
|
Adolescent Depression Rating Scale (ADRS)
Time Frame: 13 to 15 months
|
Depression (adolescent) / 10 questions / Monthly measurements, adolescent and referring psychiatrist once a month from inclusion to the end of the SCED follow-up (13 to 15 months)
|
13 to 15 months
|
|
Family Assessment Device General Functioning (FAD-GF)
Time Frame: 13 to 15 months
|
Family functioning / 12 questions, minimum = 12, maximum = 48 / Monthly measurements, parents and adolescent, once a month from inclusion to the end of the SCED follow-up (13 to 15 months)
|
13 to 15 months
|
|
Global Assessment of Functioning Scale (GAF)
Time Frame: 13 to 15 months
|
Global Functioning of the adolescent / From 0 = inadequate information, to 100 = higher level of functioning in a wide variety of activities - V-axis of the DSM 5 / Monthly measurements, referring psychiatrist, once a month from inclusion to the end of the SCED follow-up (13 to15 months)
|
13 to 15 months
|
|
CSQ 8 (Client Satisfaction Questionnaire)
Time Frame: 7 to 9 months
|
Satisfaction of the patients and the parents with multi-family therapy / 8 questions, minimum score = 8, maximum = 32 / At the end of the multifamily therapy, parents and teenager
|
7 to 9 months
|
|
Semi-structured interview
Time Frame: 7 to 9 months
|
Semi-structured interview with qualitative phenomenological analysis (patients and parents) At the end of multi-family therapy
|
7 to 9 months
|
|
Semi-structured interview
Time Frame: 19 to 21 months
|
Semi-structured interview with qualitative phenomenological analysis (patients and parents) 12 months after the end of multi-family therapy
|
19 to 21 months
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Marie-Rose MORO, MD, PhD, PU-PH, Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)
- Principal Investigator: Aurélie HARF, MD, PhD, Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP211594
- 2021-A01853-38 (Other Identifier: France : national drug safety agency)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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